Stuart Goodall is Vice President Regulatory Services Delivery and Medical Writing, with 30+ years experience in the pharmaceutical industry.
This article focuses on the impact of the new guidance document on drug-device combination (DDC) products, in Article 117 of the European Medical Device Regulation (MDR) for pharmaceutical marketing authorisation holders (MAHs). It explores the new role of the notified body (NB) versus the MAH pertaining to the device part of the DDC, some of the pitfalls encountered by pharmaceutical MAHs and potential solutions to efficiently navigate the new framework. It also provides practical insights into key technical requirements for the product-specific quality aspects of a medical device, which are within the quality dossier of a successful EU application. The article also explores efficient global implementation within fast evolving and at times divergent, regional regulations.